Medical Director, Oncology Clinical Development
GSK
16 days ago
Remote friendly (Waltham, MA)
United States
Clinical Research and Development
On-site office presence: minimum two days/week in London or Stevenage (UK), Greater Philadelphia or Waltham (US), Mississauga (Canada), Zug (Switzerland), or Warsaw (Poland).
Key Responsibilities:
- Collaborate to develop and execute phase 1–3 interventional clinical trials for hematological malignancies.
- Deliver end-to-end clinical trial oversight (protocol concept to final study report) ensuring patient safety, scientific integrity, and alignment with clinical development strategy; incorporate global considerations.
- Lead high-quality protocol development aligned with the early Clinical Development Plan.
- Provide medical responsibility for early-phase trials including real-time medical monitoring, patient eligibility, study design questions, and urgent safety questions.
- Review clinical trial data directly and/or via oversight of delegated medical review.
- Review/monitor safety data with pharmacovigilance.
- Interpret/summarize study results (safety, efficacy, PK/PD, patient-reported outcomes) and applicability to target populations.
- Author clinical study reports and regulatory documents; respond to health authority and ethics committee queries.
- Collaborate on publications; network for strategic partnerships.
- Serve on the Early Development Team and participate in Oncology Clinical Development initiatives.
Basic Qualifications:
- Medical degree with board certification/eligibility or registration qualifications in medical oncology, hematology, or hematology/oncology.
- Industry/academic medicine/practice experience in hematology and/or oncology.
- Oncology clinical drug development experience conducting trials and subsequent publications.
Preferred Qualifications:
- MD/PhD; experience managing hematological malignancies; hematological malignancy (incl. multiple myeloma) clinical research/drug development; strong translational/biological and strategy knowledge.
Benefits/Compensation (explicit): annual bonus and share-based long-term incentive eligibility; health/insurance, retirement, paid holidays, vacation, and paid caregiver/parental and medical leave.
Key Responsibilities:
- Collaborate to develop and execute phase 1–3 interventional clinical trials for hematological malignancies.
- Deliver end-to-end clinical trial oversight (protocol concept to final study report) ensuring patient safety, scientific integrity, and alignment with clinical development strategy; incorporate global considerations.
- Lead high-quality protocol development aligned with the early Clinical Development Plan.
- Provide medical responsibility for early-phase trials including real-time medical monitoring, patient eligibility, study design questions, and urgent safety questions.
- Review clinical trial data directly and/or via oversight of delegated medical review.
- Review/monitor safety data with pharmacovigilance.
- Interpret/summarize study results (safety, efficacy, PK/PD, patient-reported outcomes) and applicability to target populations.
- Author clinical study reports and regulatory documents; respond to health authority and ethics committee queries.
- Collaborate on publications; network for strategic partnerships.
- Serve on the Early Development Team and participate in Oncology Clinical Development initiatives.
Basic Qualifications:
- Medical degree with board certification/eligibility or registration qualifications in medical oncology, hematology, or hematology/oncology.
- Industry/academic medicine/practice experience in hematology and/or oncology.
- Oncology clinical drug development experience conducting trials and subsequent publications.
Preferred Qualifications:
- MD/PhD; experience managing hematological malignancies; hematological malignancy (incl. multiple myeloma) clinical research/drug development; strong translational/biological and strategy knowledge.
Benefits/Compensation (explicit): annual bonus and share-based long-term incentive eligibility; health/insurance, retirement, paid holidays, vacation, and paid caregiver/parental and medical leave.